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54 result(s) for "Jacobsohn, Eric"
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Intraoperative ketamine for prevention of postoperative delirium or pain after major surgery in older adults: an international, multicentre, double-blind, randomised clinical trial
Delirium is a common and serious postoperative complication. Subanaesthetic ketamine is often administered intraoperatively for postoperative analgesia, and some evidence suggests that ketamine prevents delirium. The primary purpose of this trial was to assess the effectiveness of ketamine for prevention of postoperative delirium in older adults. The Prevention of Delirium and Complications Associated with Surgical Treatments [PODCAST] study is a multicentre, international randomised trial that enrolled adults older than 60 years undergoing major cardiac and non-cardiac surgery under general anaesthesia. Using a computer-generated randomisation sequence we randomly assigned patients to one of three groups in blocks of 15 to receive placebo (normal saline), low-dose ketamine (0·5 mg/kg), or high dose ketamine (1·0 mg/kg) after induction of anaesthesia, before surgical incision. Participants, clinicians, and investigators were blinded to group assignment. Delirium was assessed twice daily in the first 3 postoperative days using the Confusion Assessment Method. We did analyses by intention-to-treat and assessed adverse events. This trial is registered with clinicaltrials.gov, number NCT01690988. Between Feb 6, 2014, and June 26, 2016, 1360 patients were assessed, and 672 were randomly assigned, with 222 in the placebo group, 227 in the 0·5 mg/kg ketamine group, and 223 in the 1·0 mg/kg ketamine group. There was no difference in delirium incidence between patients in the combined ketamine groups and the placebo group (19·45% vs 19·82%, respectively; absolute difference 0·36%, 95% CI −6·07 to 7·38, p=0·92). There were more postoperative hallucinations (p=0·01) and nightmares (p=0·03) with increasing ketamine doses compared with placebo. Adverse events (cardiovascular, renal, infectious, gastrointestinal, and bleeding), whether viewed individually (p value for each >0·40) or collectively (36·9% in placebo, 39·6% in 0·5 mg/kg ketamine, and 40·8% in 1·0 mg/kg ketamine groups, p=0·69), did not differ significantly across groups. A single subanaesthetic dose of ketamine did not decrease delirium in older adults after major surgery, and might cause harm by inducing negative experiences. National Institutes of Health and Cancer Center Support.
Prevention of Intraoperative Awareness in a High-Risk Surgical Population
In this trial comparing two protocols designed to reduce the risk of intraoperative awareness, a protocol that used the EEG-derived bispectral index was not superior to a protocol incorporating standard monitoring of end-tidal anesthetic-gas concentration. Unintended intraoperative awareness is defined as the experience and explicit recall of sensory perceptions during surgery, 1 which can lead to post-traumatic stress disorder in as many as 70% of those who experience it. 2 In patients at high risk for intraoperative awareness, the incidence of awareness may approach 1%. 3 – 5 An estimated 20,000 to 40,000 patients experience awareness yearly in the United States alone. 1 Some cases of awareness might occur as a result of inadequate anesthetic dosing 6 and therefore constitute potentially preventable medical errors. 7 A potent inhaled anesthetic agent is incorporated in the majority of general anesthetics, and concentrations of exhaled . . .
Anesthesia Awareness and the Bispectral Index
Anesthesia awareness has potential psychological consequences. Use of the bispectral index (BIS) developed from a processed electroencephalogram has been reported to decrease anesthesia awareness. In this randomized, controlled trial comparing a BIS-based protocol with a protocol based on measurement of end-tidal anesthetic gases, two cases of definite anesthesia awareness occurred in each group. This study did not show a benefit of BIS monitoring in reducing the rate of anesthesia awareness. This trial compared a protocol based on the bispectral index (BIS) with a protocol based on measurement of end-tidal anesthetic gases. Two cases of definite anesthesia awareness occurred in each group. This study did not show a benefit of BIS monitoring in reducing the rate of anesthesia awareness. Anesthesia awareness, also known as unintended intraoperative awareness, is the explicit recall of sensory perceptions during general anesthesia. Anesthesia awareness is rare, 1 , 2 but the incidence may approach 1% in patients at high risk. 3 – 5 Anesthesia awareness can lead to anxiety and post-traumatic stress disorder. 6 The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has recommended that stringent efforts be made to prevent anesthesia awareness, 7 and the American Society of Anesthesiologists (ASA) has published guidelines on the subject. 8 According to a sentinel-event alert disseminated by the JCAHO, between 20,000 and 40,000 cases of anesthesia awareness may occur yearly in the . . .
An examination of difficulties accessing surgical care in Canada from 2005-2014: Results from the Canadian Community Health Survey
Difficulties accessing surgical care (e.g., related to wait times, cancellations, cost, receiving a diagnosis) are understudied in Canada. Using population-based data, we studied difficulty accessing non-emergency surgical care, including (1) the incidence and annual changes in incidence, (2) types of difficulties, and (3) associated factors (e.g., sociodemographics, surgery characteristics). Cross-sectional data from the Canadian Community Health Survey annual components were analyzed from 2005-2014. Weighted frequencies established the annual incidence of difficulty accessing surgical care, and total incidence of types of difficulties. Chi-square analyses, independent samples t-tests, and a multivariable logistic regression examined sociodemographic and surgery-related characteristics associated with difficulty accessing surgical care. Among individuals who required past-year non-emergency surgery between 2005-2014 (weighted n = 3,052,072), 15.6% experienced difficulty accessing surgical care. The most common difficulty was \"waited too long for surgery\" (58.5%). There were significant differences in the incidence of difficulty according to year (Χ.sup.2 = 83.50, p < .001) from 2005-2014. The incidence of difficulty accessing surgery varied according to sex (Χ.sup.2 = 4.02, p < .05), surgery type (Χ.sup.2 = 96.09, p < .001), party responsible for cancellation/postponement (Χ.sup.2 range: 4.36-19.01, p < .05), and waiting time (t = 10.59, p < .001). In particular, males, orthopedic surgery, and surgery cancelled by the surgeon or hospital had the highest rates of difficulty.
The Appropriateness of Language Found in Research Consent Form Templates: A Computational Linguistic Analysis
To facilitate informed consent, consent forms should use language below the grade eight level. Research Ethics Boards (REBs) provide consent form templates to facilitate this goal. Templates with inappropriate language could promote consent forms that participants find difficult to understand. However, a linguistic analysis of templates is lacking. We reviewed the websites of 124 REBs for their templates. These included English language medical school REBs in Australia/New Zealand (n = 23), Canada (n = 14), South Africa (n = 8), the United Kingdom (n = 34), and a geographically-stratified sample from the United States (n = 45). Template language was analyzed using Coh-Metrix linguistic software (v.3.0, Memphis, USA). We evaluated the proportion of REBs with five key linguistic outcomes at or below grade eight. Additionally, we compared quantitative readability to the REBs' own readability standards. To determine if the template's country of origin or the presence of a local REB readability standard influenced the linguistic variables, we used a MANOVA model. Of the REBs who provided templates, 0/94 (0%, 95% CI = 0-3.9%) provided templates with all linguistic variables at or below the grade eight level. Relaxing the standard to a grade 12 level did not increase this proportion. Further, only 2/22 (9.1%, 95% CI = 2.5-27.8) REBs met their own readability standard. The country of origin (DF = 20, 177.5, F = 1.97, p = 0.01), but not the presence of an REB-specific standard (DF = 5, 84, F = 0.73, p = 0.60), influenced the linguistic variables. Inappropriate language in templates is an international problem. Templates use words that are long, abstract, and unfamiliar. This could undermine the validity of participant informed consent. REBs should set a policy of screening templates with linguistic software.
Seizures following cardiac surgery: the impact of tranexamic acid and other risk factors
Background Seizures after cardiac surgery are a serious complication. The antifibrinolytic agent tranexamic acid (TA), which has known proconvulsant properties, may be associated with postoperative seizures. We sought to determine the association between TA and other risk factors for seizures after cardiac surgery. Methods and results We analyzed a database of consecutive cardiac surgery patients (April 2003 to December 2009) using multivariable logistic regression analysis to assess for seizure risk factors. Seizures occurred in 56 of 5,958 patients (0.94%). TA use was associated with an increased risk of seizures (odds ratio 7.4, 95% confidence interval 2.8–19.3; P  < 0.001). Multivariable logistic regression analysis revealed that the following factors were significantly associated with seizures: TA exposure; Acute Physiology, Age, and Chronic Health Evaluation (APACHE) II score > 20; preoperative cardiac arrest; preoperative neurological disease; open chamber surgery; cardiopulmonary bypass time > 150 min; and previous cardiac surgery. Seizures occurred at a median of 5.3 hr (interquartile range 2.4–15.1 hr) after the end of surgery. In all, 58.1% were grand mal, 14.5% were associated with a stroke, and 58.1% recurred in hospital. Altogether, 48.3% of the patients were able to discontinue anticonvulsant medications prior to discharge. Compared to the non-seizure group, seizure patients had an increased rate of postoperative neurological complications, defined as delirium and/or stroke (3.2% vs 19.6%, P  < 0.001), increased intensive care unit (ICU) length of stay (1.0 vs 4.7 days, P   <  0.001), and increased ICU mortality (1.4 % vs 9.7 %, P  = 0.001). Conclusions Our data suggest that multiple risk factors, including TA, are associated with seizures after cardiac surgery. Thus, the TA dose may be a readily modifiable risk factor for postoperative seizures.
Hospital policy of tranexamic acid to reduce transfusion in major non-cardiac surgery (TRACTION): protocol for a phase IV randomised controlled trial
IntroductionTranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic surgeries. While the use of TXA in these surgeries is routine, its efficacy and safety in other surgeries, including oncologic surgeries, with comparable rates of transfusion are uncertain. Our primary objective is to evaluate whether a hospital-level policy implementation of routine TXA use in patients undergoing major non-cardiac surgery reduces RBC transfusion without increasing thrombotic risk.Methods and analysisA pragmatic, registry-based, blinded, cluster-crossover randomised controlled trial at 10 Canadian sites, enrolling patients undergoing non-cardiac surgeries at high risk for RBC transfusion. Sites are randomised in 4-week intervals to a hospital policy of intraoperative TXA or matching placebo. TXA is administered as 1 g at skin incision, followed by an additional 1 g prior to skin closure. Coprimary outcomes are (1) effectiveness, evaluated as the proportion of patients transfused RBCs during hospital admission and (2) safety, evaluated as the proportion of patients diagnosed with venous thromboembolism within 90 days. Secondary outcomes include: (1) transfusion: number of RBC units transfused (both at a hospital and patient level); (2) safety: in-hospital diagnoses of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism; (3) clinical: hospital length of stay, intensive care unit admission, hospital survival, 90-day survival and the number of days alive and out of hospital to day 30; and (4) compliance: the proportion of enrolled patients who receive a minimum of one dose of the study intervention.Ethics and disseminationInstitutional research ethics board approval has been obtained at all sites. At the completion of the trial, a plain language summary of the results will be posted on the trial website and distributed in the lay press. Our trial results will be published in a peer-reviewed scientific journal.Trial registration number NCT04803747.
An immersive virtual reality intervention for preoperative anxiety and distress among adults undergoing oncological surgery: protocol for a 3-phase development and feasibility trial
Background: Preoperative state anxiety (PSA) is distress and anxiety directly associated with perioperative events. PSA is associated with negative postoperative outcomes such as longer hospital length of stay, increased pain and opioid use, and higher rates of rehospitalization. Psychological prehabilitation, such as education, exposure to hospital environments, and relaxation strategies, has been shown to mitigate PSA; however, there are limited skilled personnel to deliver such interventions in clinical practice. Immersive virtual reality (VR) has the potential for greater accessibility and enhanced integration into an immersive and interactive experience. VR is rarely used in the preoperative setting, but similar forms of stress inoculation training involving exposure to stressful events have improved psychological preparation in contexts such as military deployment. Objective: This study seeks to develop and investigate a targeted PSA intervention in patients undergoing oncological surgery using a single preoperative VR exposure. The primary objectives are to (1) develop a novel VR program for patients undergoing oncological surgery with general anesthesia; (2) assess the feasibility, including acceptability, of a single exposure to this intervention; (3) assess the feasibility, including acceptability, of outcome measures of PSA; and (4) use these results to refine the VR content and outcome measures for a larger trial. A secondary objective is to preliminarily assess the clinical utility of the intervention for PSA. Methods: This study comprises 3 phases. Phase 1 (completed) involved the development of a VR prototype targeting PSA, using multidisciplinary iterative input. Phase 2 (data collection completed) involves examining the feasibility aspects of the VR intervention. This randomized feasibility trial involves assessing the novel VR preoperative intervention compared to a VR control (ie, nature trek) condition and a treatment-as-usual group among patients undergoing breast cancer surgery. Phase 3 will involve refining the prototype based on feasibility findings and input from people with lived experience for a future clinical trial, using focus groups with participants from phase 2. Results: This study was funded in March 2019. Phase 1 was completed in April 2020. Phase 2 data collection was completed in January 2024 and data analysis is ongoing. Focus groups were completed in February 2024. Both the feasibility study and focus groups will contribute to further refinement of the initial VR prototype (phase 3), with the final simulation to be completed by mid-2024. Conclusions: The findings from this work will contribute to the limited body of research examining feasible and broadly accessible interventions for PSA. Knowledge gained from this research will contribute to the final development of a novel VR intervention to be tested in a large population of patients with cancer before surgery in a randomized clinical trial.
Safety and efficacy of perioperative benzodiazepine administration: study protocol for a systematic review and meta-analysis
IntroductionPerioperative benzodiazepines are used because of their anxiolytic, sedative and amnestic effects. Evidence has demonstrated an association of benzodiazepines with adverse neuropsychiatric effects. Nonetheless, because of their potential benefits, perioperative benzodiazepines continue to be used routinely. We seek to evaluate the body of evidence of the risks and benefits of benzodiazepine use during the perioperative period.Methods and analysisWe will search Cochrane CENTRAL, MEDLINE, EMBASE, PsychINFO, CINAHL and Web of Science from inception to March 2019 for randomised controlled trials (RCTs) and observational studies evaluating the administration of benzodiazepine medications as compared with all other medications (or nothing) in patients undergoing cardiac and non-cardiac surgery. We will exclude studies assessing the use of benzodiazepines for procedural sedation or day surgery. We will examine the impact of giving these medications before, during and after surgery. Outcomes of interest include the incidence of delirium, duration of delirium, postprocedure cognitive change, the incidence of intraoperative awareness, patient satisfaction/quality of life/quality of recovery, length-of-stay (LOS) in the intensive care unit (ICU), hospital LOS and in-hospital mortality.Reviewers will screen references and assess eligibility using predefined criteria independently and in duplicate. Two reviewers will independently collect data using prepiloted forms. We will present results separately for RCTs and observational studies. We will pool data using a random effect model and present results as relative risk with 95% CIs for dichotomous outcomes and mean difference with 95% CI for continuous outcomes. We will pool adjusted ORs for observational studies. We will assess risk of bias for individual studies using the Cochrane Collaboration tool for RCTs. For observational studies, we will use tools designed by the Clinical Advances through Research and Information Translation group. Quality of evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationThis systematic review involves no patient contact and no interaction with healthcare providers or systems. As such, we did not seek ethics board approval. We will disseminate the findings of our systematic review through the presentation at peer-reviewed conferences and by seeking publication in a peer-reviewed journal.PROSPERO registration numberCRD42019128144
Disruptive behaviour in the perioperative setting: a contemporary review
Purpose Disruptive behaviour, which we define as behaviour that does not show others an adequate level of respect and causes victims or witnesses to feel threatened, is a concern in the operating room. This review summarizes the current literature on disruptive behaviour as it applies to the perioperative domain. Source Searches of MEDLINE ® , Scopus™, and Google books identified articles and monographs of interest, with backreferencing used as a supplemental strategy. Principal findings Much of the data comes from studies outside the operating room and has significant methodological limitations. Disruptive behaviour has intrapersonal, interpersonal, and organizational causes. While fewer than 10% of clinicians display disruptive behaviour, up to 98% of clinicians report witnessing disruptive behaviour in the last year, 70% report being treated with incivility, and 36% report being bullied. This type of conduct can have many negative ramifications for clinicians, students, and institutions. Although the evidence regarding patient outcomes is primarily based on clinician perceptions, anecdotes, and expert opinion, this evidence supports the contention of an increase in morbidity and mortality. The plausible mechanism for this increase is social undermining of teamwork, communication, clinical decision-making, and technical performance. The behavioural responses of those who are exposed to such conduct can positively or adversely moderate the consequences of disruptive behaviour. All operating room professions are involved, with the rank order (from high to low) being surgeons, nurses, anesthesiologists, and “others”. The optimal approaches to the prevention and management of disruptive behaviour are uncertain, but they include preventative and professional development courses, training in soft skills and teamwork, institutional efforts to optimize the workplace, clinician contracts outlining the clinician’s (and institution’s) responsibilities, institutional policies that are monitored and enforced, regular performance feedback, and clinician coaching/remediation as required. Conclusions Disruptive behaviour remains a part of operating room culture, with many associated deleterious effects. There is a widely accepted view that disruptive behaviour can lead to increased patient morbidity and mortality. This is mechanistically plausible, but more rigorous studies are required to confirm the effects and estimate their magnitude. An important measure that individual clinicians can take is to monitor and control their own behaviour, including their responses to disruptive behaviour.